Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Not Applicable

Completed

• Conditions: Colon Polyp
• Interventions: Other: Standard polypectomy; Device: Endocuff Vision assisted polypectomy

• Registration Number: NCT03117114
• Lead Sponsor: Technical University of Munich

Brief Summary

Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades.

The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-08
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-17
• Study Start: 2017-06-01
• Primary Completion: 2018-09-01
• Status Verified: 2019-06
• Study Completion: 2019-06-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• indication for colonoscopy
• age ≥ 40 years

Exclusion Criteria

• American Society of Anesthesiologists class IV or higher
• pregnant women
• indication for colonoscopy: inflammatory bowel disease
• indication for colonoscopy: polyposis syndrome
• indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
• contraindication for polyp resection e.g. patients on warfarin

Exclusion Criteria:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Arm	Standard polypectomy	Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.
Endocuff Vision Arm	Endocuff Vision assisted polypectomy	Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection.

Primary Outcome Measures

Name	Time	Method
Polyp resection	up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]	Time of polyp resection will be measured using a stopwatch.

Secondary Outcome Measures

Name	Time	Method
Total procedure duration	up to day 1	Total procedure duration
Polyp detection	up to day 1	a maximum of one day is expected for colonoscopy procedures
Ileum intubation time	up to day 1	Time span until ileum is reached
Cecal intubation time	up to day 1	Time span until cecum is reached with the tip of the scope
Patient satisfaction	up to day 1	Measured on a 10 point numeric scale
Complications	up to day 1	Bleeding, perforation and other complications
Propofol dosage	up to day 1	Amount of propofol used for colonoscopy

Trial Locations

Locations (1)

Klinikum rechts der Isar der TU München; 🇩🇪 Munich, Bavaria, Germany